Krishnachaitanya Manthripragada

About Krishnachaitanya Manthripragada

Innovative, self-motivated and successful Quality and Regulatory Compliance Leader with a strong Engineering and Research background in Mechanical and Biomedical Engineering, with hands-on experience in the highly regulated Medical Device Industry (Class Medical Devices), ISO 13485 FDA 21 CFR part 820 for Design, Product and Supplier Quality. Willing to work as a key player in a challenging and creative environment. Identified as a creative and result oriented team player.10+ years of experience with 8+ years of managerial responsibilities and proven leadership in healthcare and medical device industry. Extensive experience in NPD, Quality Systems, MFG Quality and Supplier. High volume manufacturing of Class II and Class medical devices.o Electrophysiology Catheters, Stents, Heart Valves Glucose monitoring sensors & Capital Equipment, Surgical Robotics. Certified Six Sigma Black Belt and comprehensive knowledge in Data Science and Statistical Modelling. Hiring and developing individual team members and supervisory staffAreas of Expertise• ISO 13485, ISO 9001, FDA 21 CFR part 820• Lean Manufacturing, Six Sigma Methodology.• Product/ Process Validation• Continuous Improvement • Corrective Action & Root Cause • Process Development • Supplier Quality• Project Management • Statistical Data Analysis• Risk Analysis & Management• Change Control • Sampling Theory• Quality System Design & Management• SPC• Regulatory Compliance• Team Development & Leadership• Employee Mentoring and Training• Customer & Employee Relationships • Executive PresentationsSpecialties: Control Charts, Hypothesis Testing, Correlation and Linear Regression Analysis, ANOVA, Root Cause Analysis, Design of Experiments, Six Sigma Methodologies, Lean Manufacturing, Histograms, Scatter Plots, Pareto Charts,Box Plots, Probability Plots,Matrix plots, Cause & Effect Diagrams, Measurement System Analysis Gage R&R, 5 Why Root Cause Analysis, 8D Reports, VOC, SIPOC, Process mapping, Value Stream Mapping, Response Surface Methodology, Process Capability Studies, Trend Analysis, Failure Mode & Effects Analysis, Control Plan, Regulatory Compliance.

Experience

1. Senior Engineering Manager-quality Multi Site (3)

   Medtronic

   Feb 2023 — Present · Plymouth, MN, US

   Lead 3 Manufacturing site Quality orgs to support Pharma Combo Products, Cardiac Surgery and Advanced Surgical Technologies portfolio products at Medtronic.• Lead and Support Quality engineering discipline, design transfer activities, process validation, process characterization, IQ, OQ, PQ, TMV, DOE.• Oversee and bolster the Quality organization, ensuring the production of defect-free products. Implement corporate initiatives and utilize escalation systems to build quality into the product, while maintaining effective tracking of escalations-CAPA Board Chair for the Plymouth CAPA Board.• Direct and facilitate Quality Management Systems for the sites by maintaining and continuously improving the effectiveness and agility of quality management systems. Ensure the site is audit ready every day and champion the sites through audits 0 Findings.• Collaborate with Site Ops leaders to create a winning strategy for sites quality organizational support to develop a culture of putting patients first.

Education

• University of Louisiana at Lafayette

  Master's degree, Mechanical Engineering (Medical Device Design)

• Jawaharlal Nehru Technological University

  Bachelor's degree, Mechanical Engineering

Skills

• Technical Documentation
• Quality Control
• Autocad
• Tqm
• Microsoft Office
• Root Cause Analysis
• Simscape
• Teaching
• Quality Assurance
• Cfd
• V&V
• Labview
• Medical Device R&D
• C++
• Mechanical Engineering
• Minitab
• Public Speaking
• Research
• Html
• Finite Element Analysis
• Gambit
• Fmea
• Techinical Writing
• Ansys
• Quality Management
• University Teaching
• Arduino
• Spc
• Jmp
• Simulations
• Data Analysis
• Product Design
• Strategic Planning
• Quality Auditing
• Project Management
• Solidworks
• Fluent
• Powerpoint
• Microsoft Excel
• Engineering